Difference between revisions of "Adverse drug event"

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'''An adverse event''' is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:
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'''An adverse event (ADE)''' is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to [[U.S. Food and Drug Administration (FDA)]] when the patient outcome is:
  
 
* Death
 
* Death
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* Required Intervention to Prevent Permanent Impairment or Damage (Devices)
 
* Required Intervention to Prevent Permanent Impairment or Damage (Devices)
 
* Other Serious (Important Medical Events)
 
* Other Serious (Important Medical Events)
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== Clinical Decision Support ==
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Rules for ADE are often used in [[CDS|clinical decision support systems]].
  
 
== Important interactions ==
 
== Important interactions ==

Revision as of 18:41, 17 November 2011

An adverse event (ADE) is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to U.S. Food and Drug Administration (FDA) when the patient outcome is:

  • Death
  • Life-threatening
  • Congenital Anomaly/Birth Defect
  • Required Intervention to Prevent Permanent Impairment or Damage (Devices)
  • Other Serious (Important Medical Events)

Clinical Decision Support

Rules for ADE are often used in clinical decision support systems.

Important interactions

References

  1. What is a Serious Adverse Event? FDA. [1]